MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW GAMMA3® 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13200090

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

As reported: "the nail gets stuck in the target device gamma3.The procedure was completed with another instrument.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported event could be confirmed, since the devices were stuck as complained.The target device, the nail holding screw and the nail were returned in assembled condition.During the evaluation it was possible to disassemble the devices by applying very high force, based on that the complaint can be confirmed.After disassembly it was detected that there was a lot of reddish residues at the screw shaft and the thread.Also at the target device nail interface are a many residues visible.The visual inspection of the holding screw has shown that the hexagon recess is strongly worn, there are many scratches visible and the surfaces of the hexagon have impression marks from intense use.However, as the function test has shown have these damages no influence on the function of the device.But the damages indicate that the holding screw was previously often used without any issues.After re-decontamination of the disassembled devices as function test was made.The devices could be assembled, tightened and disassembled without any issue, the complained malfunction that the nail gets stuck with the target device could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.The device inspection revealed the following: a review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected.Based on investigation, the root cause was attributed to a user related issue.The event was most likely caused by combination of overtightening and the high amount of residues that was detected on the thread of the nail holding screw.The residues are an indication for an intra-operative loosing and re-tightening of the connection as the devices should be assembled before they come in contact with the patient.If more information is provided, the case will be reassessed.

Event Description

As reported: "the nail gets stuck in the target device gamma3.The procedure was completed with another instrument.".

• Brand Name: NAIL HOLDING SCREW GAMMA3® 8X35MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18610688
• MDR Text Key: 334258048
• Report Number: 0009610622-2024-00048
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200090
• Device Lot Number: KSS22315Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1